Medical Device Daily Contributing Writer

CHICAGO — The annual meeting of the American Academy of Ophthalmology (AAO; San Francisco), the largest ophthalmic meeting of the year, took place here last week, with an estimated 30,000 persons from around the world in attendance.

In addition to providing physicians with an opportunity to learn about the latest clinical developments in their field, public ophthalmic companies often have meetings to update the investment community and media about their most current information. However, with the 2009 acquisition of Advanced Medical Optics (Santa Ana, California) by Abbott Laboratories (Abbott Park, Illinois) (MDD, Feb. 26, 2009) and the likely acquisition of Alcon (Fort Worth, Texas) by Novartis International (Basel, Switzerland), the only public ophthalmic company that presented to the financial community was Staar Surgical (Monrovia, California).

Staar's analyst meeting was heavily focused on two topics – its flagship Visian ICL and its Collamer Accommodating Study Team (CAST).

The Visian, which is a phakic intraocular lens (IOL) designed to treat higher levels of myopia as well as combined high myopia and astigmatism, has registered very rapid growth in the past couple of years. Indeed, according to a recent Staar press release, the number of Visian ICLs implanted has doubled between 2008 and 2010. This product line now accounts for approximately 45% of Staar's global sales.

One of the featured speakers at this meeting was Erik Mertens, MD, who is the director of the Antwerp Eye Center (Antwerp, Belgium). Mertens, who is a very active refractive surgeon, has implanted well over 1,000 Visian ICLs since 2003. He noted that in 2009 about 23% of his refractive correction patients received an ICL, vs. only 6% in 2004.

He attributed this surge to his “rapid increase in confidence“ in the ICL technology, resulting from extremely high patient satisfaction, a very predictable outcome and minimal complications.

He went on to say that “I expect that our ICL implants will increase to 25% of our practice in 2010 and about 30% in 2011.“

Mertens credited this anticipated surge in ICL implants in 2010 and 2011 to four key factors, First, Staar recently began offering lower dioptric ranges for both myopic and hyperopic patients, which are now available in 0.25 diopter increments. This will enable patients with lower levels of myopia and astigmatism to have access to an ICL instead of LASIK.

Second, Staar has lowered the price of ICLs which correct moderate levels of myopia and hyperopia, enabling this technology to compete more effectively with LASIK.

Third, refractive surgeons are increasingly aware of and concerned with LASIK-induced corneal ectasia, or the progressive steepening and bulging of the cornea.

Fourth, the recent availability of the Visian toric hyperopic ICL and the ability to treat mixed astigmatism will significantly increase the addressable market with the Visian ICL. An indication of the growing confidence in the ICL occurred in Paris at the September 2010 annual meeting of the European Society of Cataract and Refractive Surgery (Dublin, Ireland). An interactive response system of the attendees at Staar's ICL Expert's Meeting revealed that 40% of the polled group said that within five years, 40% of all refractive procedures would be with phakic intraocular lenses (IOLs).

A second refractive/cataract surgeon, Kenneth Lipstock, MD, from the Lipstock LASIK and Cataract Center (Richmond, Virginia) provided a comprehensive update on Staar's Collamer Accommodating Study Team (CAST). This study, which uses the company's collamer nanoFLEX IOL for the treatment of cataracts, showed that intermediate vision achieved was better than that for any standard IOL on the market, and that the near vision results were better than those of any standard IOL. Like all standard IOLs, it achieves good distance vision.

A larger study, called CAST II, is designed to raise the quality of the data to a clinical trial level with a protocol to support a claim of either best in class at intermediate or best in class at near vision. This could enable the nanoFLEX to gain a New Technology IOL status, which would allow for a higher average selling price or provide the product with an entry point into the premium IOL segment, where ASPs are several fold higher than standard IOLs.

Management said it recently received information from the FDA regarding the design of this new clinical trial and that the studies could begin before the end of the year.

In addition to providing an encouraging update on CAST results, Lipstock provided an early glimpse at the newer Monofocal Accomodating Study Team (MAST) trial. This study is using the nanoFLEX for “monovision“ correction, that is, one eye corrected for distance, one eye corrected for reading. MAST data showed that with less than a 2 diopter offset, on average his patients could achieve 20/20 distance vision and 20/25 near vision.

Lipstock termed these results as “shockingly good for near and intermediate vision“ further adding that “the nanoFLEX IOL is a great option for patients who do not want to spend extra money for presbyopic correction.“

CEO Barry Caldwell provided a brief review of the company's regulatory activities for the Visian toric ICL. In foreign markets where it is widely approved, it accounts for 40% to 50% of overall ICL sales. However, it is not yet approved in two key refractive correction markets–the U.S. and Japan.

On the domestic front, Staar continues to have an active and regular dialogue with the FDA. Caldwell gave no indication as to when this lens could be approved, having quipped several months ago that “I am out of the predicting business.“

Staar applied for Japanese approval in April 2010 and Caldwell said that he hopes for approval in the second half of 2011.

Femtosecond laser-assisted cataract surgery (FLACS) was one of the hottest topics at this year's meeting, with privately-owned OptiMedica (Santa Clara, California), LensAR (Orlando, Florida) and LenSx (Aliso Viejo, California), recently acquired by Alcon Laboratories (Fort Worth, Texas) all showing their FLACS systems on the exhibit floor.

All three booths were packed, as surgeons were very eager to test drive the systems and see which one offered the most attractive features and benefits. None of the companies are shipping product as yet and it appears that commercialization will not occur until the second half of 2011.

The consensus view is that all three systems are relatively similar and will provide surgeons with excellent clinical results. In the words of John Vukich, MD, a noted cataract and refractive surgeon from the Davis Duehr Dean Center for Refractive Surgery (Madison, Wisconsin) and a member of OptiMedica's medical advisory board “all three of the platforms use similar concepts and view the market similarly in terms of the platform's appeal . . . it will come down to the delivery of the unit, including such things as are the ergonomics consistent with OR flow? Is it easy to use? Is the interface friendly for the surgeon? Does it provide a rapid turnaround?“

The pricing models have yet to be determined either but scuttlebutt at the show was that these lasers will sell for between $400K and $500K, with a per procedure click fee of about $250.

In addition to these three, several other companies are known to be developing FLACS devices. These include Abbott Medical Optics, Carl Zeiss (Oberkochen, Germany), Schwind (Kleinostheim, Germany) and Technolas Perfect Vision (Munich, Germany).

At an AAO-sponsored press briefing, renown refractive and cataract surgeon Richard Lindstrom, MD, of Minnesota Eye Consultants (Minneapolis) discussed FLACS, stating that there are significant limitations with the current manual method of performing cataract surgery. He indicated that whereas LASIK has experienced tremendous technological evolution in the past decade, cataract surgery has had minimal advances and continues to provide mediocre visual outcomes as well as having some safety issues.

He provided data from several relative small clinical trials that clearly demonstrate that FLACS provides a safer outcome than a manual procedure.

In particular, Lindstrom cited a study that was reported in the December 2009 issue of the Journal of Refractive Surgery that showed that 100% of all LenSx FLACS procedures achieved a post-procedure accuracy of ± 0.25 millimeters, compared to only 10% of manual procedures that attained an accuracy of ±0.25 millimeters.

He also mentioned another study done by LenSx that revealed a 54% reduction in phaco-emulsification power requirements and a 60% drop in endothelial cell loss.

Lindstrom ebulliently concluded “this extremely precise laser driven scalpel is the future of cataract surgery and will usher in a new age for cataract surgeons and their patients.“

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